Penile Squamous Cell Carcinoma (PSCC)Phase 2NCT02541903
Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma
A Phase 2 study testing Gilotrif in people with Penile Squamous Cell Carcinoma (PSCC), run by University of Alabama at Birmingham at 3 sites in United States.
Trial summary
Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease. Supportive evidence for the value of systemic therapy does not exist for this disease and there are no agents currently approved by regulatory agencies. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Penile Squamous Cell Carcinoma (PSCC)
- What is being tested?
- Gilotrif
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2015to Apr 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed PSCC.
- Patients with metastatic or locally advanced unresectable PSCC.
- Progressive disease after ≥1 prior chemotherapy regimens.
- Measurable disease by RECIST 1.1 criteria.
- Prior regimen within 6 months
- ECOG performance status 0-2.
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- Adequate organ function, defined as all of the following:
- Absolute neutrophil count (ANC) >1500 /mm3. Platelet count >100,000/ mm3.
- Estimated creatinine clearance ≥ 45ml/min.
- Total Bilirubin <1.5 times upper limit of institutional normal; Aspartate amino transferase (AST) or alanine amino transferase (ALT) <2.5 times the upper limit of institutional normal (ULN).
- Hemoglobin ≥8.5 g/dl.
- Resolution of all acute toxic effects of prior chemotherapy or surgical procedures to NCI CTCAE version 4.03 grade <1, in the opinion of the Treating Physician.
- Ability to understand and willingness to sign a written informed consent. Age ≥18 years or age of majority at the participating site, whichever is greater.
- Availability of 20 archival formalin-fixed paraffin embedded tumor tissue slides.
Who cannot join
- Patients will have recovered from toxicities from prior systemic anticancer treatment or local therapies.
- Prior EGFR inhibitors.
- Major surgery within 4 weeks or minor surgery within 2 weeks before registration or scheduled for surgery during the projected course of the study. Wounds will be completely healed prior to study entry and patients recovered from all toxicities from surgery. Placement of vascular access device is not considered major or minor surgery in this regard.
- Prior radiation therapy is allowed as long as the irradiated area was not the sole source of measurable disease and radiotherapy was completed with recovery from toxicity, at least 3 weeks prior to enrollment. If the irradiated area is the only site of disease, there will be progressive disease.
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to registration.
- Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug.
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- Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
- Requiring treatment with any of the prohibited concomitant medications listed in the protocol that cannot be stopped for the duration of trial participation.
- Known pre-existing interstitial lung disease.
- Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption).
- Active hepatitis B infection (defined as presence of Hep BsAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier.
- Meningeal carcinomatosis.
- Patients with active brain or subdural metastases are not eligible, unless they have completed local (radiation) therapy and have discontinued the use of corticosteroids or have been on stable dose of corticosteroids for at least 4 weeks before starting study treatment. Any symptoms attributed to brain metastases will be stable for at least 4 weeks before starting study treatment.
- Any active or uncontrolled infection.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
MD Anderson Cancer Center
Houston, Texas, 77030
University of Southern California
Los Angeles, California, 90033
About this study
Official title: A Phase 2 Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma Following Systemic Therapy
Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease. Supportive evidence for the value of systemic therapy does not exist for this disease and there are no agents currently approved by regulatory agencies. This study will evaluate the drug Gilotrif in patients with metastatic progressive PSCC following chemotherapy. Gilotrif has shown supportive evidence in non-small cell lung cancer by inhibiting certain proteins that are also found in PSCC. The drug has the potential for some patients to exhibit a response contributing to a greater quality of life.
Read the detailed description
This is a non-randomized trial phase 2 trial in which the drug Gilotrif will be administered at an oral dosage of 40 mg daily. This will continue until there is disease progression or severe toxicities. Patients will undergo a clinical exam every 4 weeks as well as have blood collected. Radiographic scans will be done every 8 weeks.
- Conditions
- Penile Squamous Cell Carcinoma (PSCC)
- Being tested
- Gilotrif
- Keywords
- Epidermal growth factor receptor (EGFR),, Human Papillomavirus (HPV), Penile squamous cell carcinoma (PSCC), Gilotrif
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GilotrifDrug
Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur.
| Study group | Role | What they receive |
|---|---|---|
| Gilotrif | Experimental | Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks). Receives: Drug: Gilotrif |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Progression Free Survival at 6 Months
Death will signify the time of progression free survival. Otherwise, the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 will be used to evaluate disease progression. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 6 months following study treatment
Secondary outcomes (3)
Response Rate
The Response Evaluation Criteria in Solid Tumors guidelines version 1.1 and disease assessment scans (bone, CT) will be used to evaluate tumor response.
Measured: Baseline up to 3 months
Overall Survival
From date of study enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 30 months.
Measured: Baseline to death (assessed up to 30 months).
Toxicities
The number of adverse events and serious adverse events will be tabulated using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Measured: Baseline up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startOct 2015
- Primary completion26 Jan 2019
- Study completionApr 2020
Why it stopped: poor overall accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Penile Squamous Cell Carcinoma (PSCC)Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisle Nabell, University of Alabama at Birmingham
- Investigators
- Lisle Nabell, MD, Principal investigator, University of Alabama at BirminghamTanya Dorff, MD, Study chair, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541903
- Sponsor's protocol ID
- F150330009 (UAB 14113)
- Status last verified
- Apr 2020
- First submitted
- 24 Aug 2015
- Last updated
- 14 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma Following Systemic Therapy
- ClinicalTrials.gov ID
- NCT02541903
- Acronym / sponsor ID
- F150330009 (UAB 14113)
- Conditions
- Penile Squamous Cell Carcinoma (PSCC)
- Keywords
- Epidermal growth factor receptor (EGFR),, Human Papillomavirus (HPV), Penile squamous cell carcinoma (PSCC), Gilotrif
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor overall accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 26 Jan 2019 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Posted 14 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease. Supportive evidence for the value of systemic therapy does not exist for this disease and there are no agents currently approved by regulatory agencies. This study will evaluate the drug Gilotrif in patients with metastatic progressive PSCC following chemotherapy. Gilotrif has shown supportive evidence in non-small cell lung cancer by inhibiting certain proteins that are also found in PSCC. The drug has the potential for some patients to exhibit a response contributing to a greater quality of life.
Detailed description
This is a non-randomized trial phase 2 trial in which the drug Gilotrif will be administered at an oral dosage of 40 mg daily. This will continue until there is disease progression or severe toxicities. Patients will undergo a clinical exam every 4 weeks as well as have blood collected. Radiographic scans will be done every 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gilotrif | Experimental | Drug: GilotrifGilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically confirmed PSCC.
- Patients with metastatic or locally advanced unresectable PSCC.
- Progressive disease after ≥1 prior chemotherapy regimens.
- Measurable disease by RECIST 1.1 criteria.
- Prior regimen within 6 months
Key exclusion criteria (14 listed)
- Patients will have recovered from toxicities from prior systemic anticancer treatment or local therapies.
- Prior EGFR inhibitors.
- Major surgery within 4 weeks or minor surgery within 2 weeks before registration or scheduled for surgery during the projected course of the study. Wounds will be completely healed prior to study entry and patients recovered from all toxicities from surgery. Placement of vascular access device is not considered major or minor surgery in this regard.
- Prior radiation therapy is allowed as long as the irradiated area was not the sole source of measurable disease and radiotherapy was completed with recovery from toxicity, at least 3 weeks prior to enrollment. If the irradiated area is the only site of disease, there will be progressive disease.
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to registration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GilotrifPatients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur. | Drug | Gilotrif |
Primary outcome
Number of Participants With Progression Free Survival at 6 Months
Time frame: 6 months following study treatment
Death will signify the time of progression free survival. Otherwise, the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 will be used to evaluate disease progression. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
3 secondary outcomes
Response Rate
Time frame: Baseline up to 3 months
Overall Survival
Time frame: Baseline to death (assessed up to 30 months).
Toxicities
Time frame: Baseline up to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Penile Squamous Cell Carcinoma (PSCC)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisle Nabell, MD principal investigator
University of Alabama at Birmingham
Tanya Dorff, MD study chair
University of Southern California
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gilotrif in people with Penile Squamous Cell Carcinoma (PSCC), run by University of Alabama at Birmingham at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Progression Free Survival at 6 Months (time frame: 6 months following study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020; AzTrials last refreshed its copy on 26 Oct 2026.